{"id":4341,"date":"2023-08-01T16:16:04","date_gmt":"2023-08-01T08:16:04","guid":{"rendered":"https:\/\/regask.com\/?p=4341"},"modified":"2024-10-26T02:56:36","modified_gmt":"2024-10-25T18:56:36","slug":"lignes-directrices-de-sante-canada-sur-la-therapie-genique","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/health-canada-gene-therapy-guidelines\/","title":{"rendered":"Sant\u00e9 Canada met en \u0153uvre la ligne directrice de l\u2019ICH sur les tests non cliniques"},"content":{"rendered":"<div>\n<div>Sant\u00e9 Canada a annonc\u00e9 la mise en \u0153uvre de la ligne directrice S12 sur les consid\u00e9rations relatives \u00e0 la biodistribution non clinique pour la th\u00e9rapie g\u00e9nique.<\/div>\n<\/div>\n<div><\/div>\n<div>La ligne directrice selon l&#039;ICH<\/div>\n<ul>\n<li>Fournit des recommandations harmonis\u00e9es pour la conduite d\u2019\u00e9tudes de biodistribution non clinique (BD) dans le d\u00e9veloppement de produits de th\u00e9rapie g\u00e9nique (GT) ;<\/li>\n<li>Comprend des recommandations pour faciliter le d\u00e9veloppement de produits GT tout en \u00e9vitant l\u2019utilisation inutile d\u2019animaux, conform\u00e9ment aux principes des 3R (r\u00e9duire\/affiner\/remplacer) ;<\/li>\n<li>Formule des recommandations pour la conception globale des \u00e9valuations BD non cliniques.<\/li>\n<\/ul>\n<p>Besoin d&#039;en savoir plus sur les changements de r\u00e9glementation concernant les produits th\u00e9rapeutiques ? <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/fr\/categorie\/dernieres-informations\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-597583433\">\n\n\t<div id=\"col-82079026\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy. The guideline according to ICH Provides harmonized recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products; Includes recommendations to facilitate the development of GT products while avoiding unnecessary use of animals,&#8230;<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[513,39],"tags":[40],"class_list":["post-4341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-canada-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Canada Adopts ICH Gene Therapy Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"Health Canada implements ICH guideline on nonclinical biodistribution considerations for gene therapy products. Stay compliant with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/lignes-directrices-de-sante-canada-sur-la-therapie-genique\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Canada Implements ICH Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products\" \/>\n<meta property=\"og:description\" content=\"Health Canada implements ICH guideline on nonclinical biodistribution considerations for gene therapy products. Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/lignes-directrices-de-sante-canada-sur-la-therapie-genique\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-01T08:16:04+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T18:56:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Health Canada Implements ICH Guideline on Nonclinical B&hellip;\",\"datePublished\":\"2023-08-01T08:16:04+00:00\",\"dateModified\":\"2024-10-25T18:56:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\"},\"wordCount\":167,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Canada\",\"Medical Devices\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/\",\"name\":\"Canada Adopts ICH Gene Therapy Guidelines | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/health-canada-gene-therapy-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"datePublished\":\"2023-08-01T08:16:04+00:00\",\"dateModified\":\"2024-10-25T18:56:36+00:00\",\"description\":\"Health Canada implements ICH guideline on nonclinical biodistribution considerations for gene therapy products. 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